The short answer
Importation must be handled by a mainland enterprise holding the required import qualifications, and institutions purchase through them. There are usually three routes: general-trade importation for products already registered in the mainland; the Hong Kong-Macao Medicine and Device Connect scheme, through which designated Greater Bay Area hospitals bring in clinically urgent medicines already marketed in Hong Kong or Macao; and, for other clinically urgent cases, the temporary-import channels set out in national rules. In every route the Hong Kong licensed wholesaler plays the same part: the compliant supplier on the Hong Kong side, responsible for source verification, licensing, documentation and cold-chain hand-over. Where the need is an individual patient rather than an institution, a further route exists: direct mail from Hong Kong for personal use under the customs rules for personal postal items (see section 05).
01
Three routes, and who does what
General-trade importation: the product holds a mainland import drug registration (or is treated as registered under current rules). A licensed mainland importer declares it, the port drug-testing institute samples it, and the goods enter distribution once the clearance certificate is issued. This suits products already on the mainland market that need steady, ongoing supply. On the Hong Kong side we locate stock matching the mainland-registered version, verify documents, and complete export licensing and temperature-controlled transport.
Hong Kong-Macao Medicine and Device Connect: designated medical institutions in the nine mainland cities of the Greater Bay Area may bring in clinically urgent medicines and devices already marketed in Hong Kong or Macao, under a catalogue and approval procedure administered by the Guangdong provincial drug regulator. The institution is the applicant; we provide Hong Kong-side product information, supply confirmation and documentation, and do not handle the approval on its behalf.
Temporary importation for clinical urgency: a small number of clinically urgent medicines not yet registered in the mainland may be imported temporarily by specific institutions under the rules of the national drug and health authorities, the special import arrangement of the Hainan Boao Lecheng pilot zone being one example. The scope is narrow and every case is approved individually, so confirm with the authorities before discussing supply.
What the three routes share: importation and port procedures are always handled by a licensed mainland entity, and the institution never imports on its own. Any workaround that bypasses the importer, such as personal carriage, purchasing agents, or using personal direct-mail or cross-border e-commerce goods for institutional procurement, is non-compliant.
02
What must be in order on the Hong Kong side
Supplier credentials: a Hong Kong wholesale dealer licence can be checked by company name in the Drug Office online register; deal only with wholesalers on that register.
Product status in Hong Kong and export licensing: controlled pharmaceutical products generally need a per-shipment export licence, and unregistered medicines intended for re-export can be assessed under the PLAMMS arrangement. Both are handled shipment by shipment, and the outcome decides whether goods can move.
Documents: commercial invoice, packing list, batch and expiry schedule, and storage and transport temperature records. Source documents and certificates of analysis are confirmed per order according to what the supplier provides; we do not promise that every batch carries them.
Cold chain: the transport window and packaging follow the temperature requirement on the product label, and temperature data is retained per batch.
03
Who owns what on the mainland side
The importer: import filing or declaration, customs clearance, port inspection, the clearance certificate, and incoming-goods inspection records once the product enters distribution.
The institution: the purchase contract with the importer, receiving and warehousing, and the incoming inspection and traceability records required; institutions using Medicine and Device Connect also own the application, usage management and adverse-reaction monitoring.
The Hong Kong wholesaler: prepares Hong Kong-side documents to the importer's requirements and supports port inspection and batch tracing, without completing mainland clearance on the importer's behalf.
04
Estimating timelines and cost
There is no universal timeline. Product category, mainland registration status, licensing, port inspection arrangements and cold-chain transport windows all move the schedule, and costs are calculated per shipment as well. The reliable approach is per-shipment assessment: once the route is confirmed we provide a staged written estimate and quotation, and report progress at each milestone.
05
Personal use: direct mail from Hong Kong
The first four sections cover institutional procurement. Where the need is an individual patient, for example when a doctor recommends an imported version not yet marketed in the mainland, the institution cannot import on the patient's behalf, but the individual may buy by direct mail from Hong Kong for personal use under the customs rules for personal postal items.
This is the personal-items channel, not cross-border e-commerce retail import. These medicines sit outside the cross-border e-commerce retail import list, so bonded-warehouse stocking (1210) and the list-based model do not apply; they can only be direct-mailed from Hong Kong parcel by parcel as personal-use items, supervised by customs under the rules for personal postal items.
Personal use, in reasonable quantities: the buyer is an individual and may not resell. Personal items posted from Hong Kong are subject to a value limit of RMB 800 per consignment; a single indivisible item above the limit can still be handled as a personal item once customs confirms it is for personal use. Any tax due is levied at the postal-articles rate, and amounts of RMB 50 or below are exempt.
Category boundary: prescription medicines can be bought by personal direct mail; narcotic drugs, pharmaceutical precursor chemicals and other medicines that regulations bar from online sale, such as psychotropic drugs, vaccines and blood products, are excluded. Customs may ask for an explanation of purpose or supporting materials, or return the parcel.
Our role: our official storefronts on JD Worldwide, Tmall Global, Meituan and Pinduoduo operate under this model, run by our own team, with goods dispatched parcel by parcel by the licensed party in Hong Kong. Whether a product can be listed and sold depends on platform review and customs rules.
How institutions can help: the doctor can tell the patient the product name and version, and the patient orders from the official storefront directly. The institution does not handle the purchase or payment, and does not bring such goods into hospital use.
FAQ
Frequently asked questions
- Can a hospital buy medicines directly from a Hong Kong wholesaler?
- No. Importation must be handled by a licensed mainland importer, and institutions purchase through them; under Medicine and Device Connect, designated hospitals bring products in through an approval procedure, which is likewise not a direct purchase.
- Is Medicine and Device Connect limited to designated institutions?
- Yes. It is currently limited to approved designated medical institutions in the nine mainland cities of the Greater Bay Area, with products governed by the catalogue and approvals.
- Can medicines bought through cross-border channels be used for patients?
- Institutions may not use personally direct-mailed or cross-border e-commerce goods for procurement or clinical use. Individual patients may buy by direct mail from Hong Kong for personal use under the personal-items rules (see section 05), in reasonable quantities; prescription medicines are allowed, while narcotic drugs, precursor chemicals and other medicines barred from online sale are not.
- Which documents can a Hong Kong wholesaler provide?
- Commercial invoice, packing list, batch and expiry schedule, temperature records, and export-licence details handled per shipment; source documents and certificates of analysis are confirmed per order according to what the supplier provides.
- What should we prepare before enquiring?
- Institution name and credentials, the intended route, product name, dosage form, strength and target version, quantity and target timing, importer details if already appointed, and destination and storage conditions.
READ BEFORE ENQUIRING
Conditions requiring case-by-case confirmation
- ✓General information only, not legal advice; requirements follow current regulations and regulator guidance in both jurisdictions
- ✓Mainland entry and clearance are led by the licensed mainland importer; Hong Kong licensing does not guarantee import approval at the destination
- ✓Timelines and costs are assessed per shipment and confirmed in writing
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